Vivance, a leader in kidney care innovations, is proud to announce that the next trial phase of the wearable peritoneal dialysis (PD) device, Viva Kompact, has successfully concluded. The study was conducted at Singapore General Hospital (SGH), Singapore. The study data will be shared at American Society of Nephrology (ASN) Kidney Week, happening from 23-27 October 2024 at the San Diego Convention Center.

Viva Kompact received US Food and Drug Administration (FDA)’s breakthrough device designation in 2019 following the completion of the First-in-Human clinical trial. Earlier this year, the pre-pivotal trial was completed, focusing on evaluating the device’s performance and safety parameters while being independently used by patients in their home environment.

“Completing this trial is a momentous achievement for our team, patients and healthcare professionals who are equally passionate about advancing kidney care to the next level,” said Suresha Venkataraya, CEO of Vivance. “We are excited to share our findings, which we believe will contribute significantly to advancing the possibility of dialysis anytime, anywhere.”

The trial results will be presented during oral sessions at Kidney Week by A/Prof. Marjorie Foo, the Principal Investigator and Senior Consultant, Department of Renal Medicine, SGH, who said, “I am excited to share the findings from this first-of-a-kind wearable dialysis device which underwent a trial at Singapore General Hospital. 10 patients were able to independently use the device and successfully complete at least one week of dialysis at their homes, with no device-related serious adverse events.” The presentation will provide more information on the performance, efficacy and patient experience of using this wearable device.

Mandar Gori, Chief Business Officer of Vivance, who also heads the Clinical Affairs function, said, “We thank all collaborators, especially our clinical advisors, who made the pre-pivotal trial of this FDA-designated breakthrough device possible. We are excited to showcase Viva Kompact along with our other products at booth #829 during the upcoming ASN Kidney Week.”

Press release here- https://www.prnewswire.com/news-releases/vivance-completes-pre-pivotal-trial-of-wearable-dialysis-device-results-to-be-shared-at-asn-kidney-week-2024-302274569.html